news
$1.7b acquisition to develop rare haematology therapy
When CTI BioPharma is acquired by Swedish Orphan Biovitrum AB (Sobi), the companies intend to advance an oral kinase inhibitor treatment for a rare haematological disease.
List view / Grid view
Swedish Orphan Biovitrum (SOBI)
news
EC approves Zynlonta® for large B-cell lymphoma
Antibody drug conjugate Zynlonta® (loncastuximab tesirine) is approved in the European Union for treatment of relapsed or refractory diffuse large B-cell lymphoma.
news
Efanesoctocog alfa prevents bleeding episodes in haemophilia A patients
Efanesoctocog alfa significantly and meaningfully reduces annualised bleeding rates in haemophilia A patients, according to new Phase III data.
news
FDA approves higher strength Orfadin capsule for HT-1
15 June 2016 | By Victoria White, Digital Content Producer
The FDA has approved a higher strength 20mg capsule of Sobi's Orfadin (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1)...
news
EC approves Alprolix for the treatment of haemophilia B
13 May 2016 | By Victoria White, Digital Content Producer
The European Commission has approved Alprolix (rFIXFc) for the treatment of haemophilia B and maintained its orphan designation...
news
CHMP adopts positive opinion of haemophilia B treatment, Alprolix
26 February 2016 | By Victoria White
Alprolix is a recombinant clotting factor therapy developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1...
news
EC gives nod to haemophilia A treatment Elocta
26 November 2015 | By Victoria White
Elocta will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days...
news
CHMP recommends Elocta for haemophilia A
25 September 2015 | By Victoria White
Elocta is a recombinant factor VIII Fc fusion protein product that, if approved, would be the first haemophilia A treatment with prolonged circulation available in the EU...
news
B-YOND study results reinforce long-term clinical profile of Alprolix
18 August 2015 | By Victoria White
Interim results from the B-YOND study support the long-term safety and efficacy of Alprolix in people with severe haemophilia B treated for up to two years...
news
European Commission approves Orfadin oral suspension
29 June 2015 | By Victoria White
The European Commission (EC) has approved the oral suspension formulation of Sobi’s Orfadin for the treatment of Hereditary Tyrosinaemia type-1 (HT-1)...
news
European Medicines Agency validates Alprolix marketing authorisation application
26 June 2015 | By Victoria White
Biogen and SOBI have announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) for Alprolix...
news
Leading hematology journal publishes pivotal ELOCTATE™ data that demonstrated efficacy and safety of investigational long-lasting therapy for hemophilia A
13 November 2013 | By Biogen Idec
Phase 3 study showed potential for once- or twice-weekly prophylactic dosing regimens...
news
New Phase 3 data reinforce long-lasting protection from bleeding for patients with Hemophilia A and B
8 February 2013 | By Biogen Idec
Biogen Idec and Swedish Orphan Biovitrum released data...
news
Biogen Idec and Sobi announce positive top-line results from Phase 3 study investigating long-lasting recombinant Factor VIII Fc fusion protein in Hemophilia A
31 October 2012 | By Biogen Idec
Biogen Idec and Swedish Orphan Biovitrum announced positive results from A-LONG...
news
Biogen Idec and SOBI initiate global clinical trials of long-lasting hemophilia A and B product candidates in children
5 July 2012 | By Biogen Idec
Biogen Idec and SOBI announced the initiation of two global pediatric clinical trials...
